Longeveron Pioneering Development of Stem Cell Therapies for Aging Frailty

therapies for age-related diseases, announced that the company is progressing with the development of its stem cell treatment to ameliorate aging frailty. The company is building on Phase 1 safety and Phase 2 safety, tolerability and efficacy studies

conducted by the University of Miami Miller School of Medicine of Allogeneic Mesenchymal Stem Cells (MSCs) in patients with aging frailty. The results of both studies were published in the October 12 issue of the Journals of Gerontology.

Based on its review of these papers, the Oxford University Press Journals of Gerontology published an editorial in the same issue confirming that "MSC transplantation is a promising and innovative approach for the treatment of frailty in older humans" and "stem cells might be the vehicles for youthful regeneration of aged tissues."

"With the aging of the population, stem cells hold great promise to treat aging-related disability and frailty, improving physical capacity and quality of life. There is no FDA approved treatment for aging frailty and an enormous unmet need that will only increase with the changing demographics. We are following a very careful, very rigorous testing process for FDA approval to provide safe and effective stem cell therapies," said Joshua M. Hare, M.D., Longeveron Chief Science Officer and Co-Founder and Director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine.

"This pioneering Phase 2 study has shown that MSC treatment is safe in this patient population and produces remarkable improvement in function and immunologic levels, confirming the outcomes shown in the company's Phase 1 clinical trial. The positive results demonstrated by the research are also extremely significant in that they clearly point to the need for continued clinical development of cell-based therapy for aging frailty," said Samuel Golpanian, M.D., of the Department of Surgery, University of Miami's Miller School of Medicine/Jackson Memorial Hospital, lead author of the Phase 1 trial. Bryon Thompkins, M.D., of the Department of Surgery, UM's Miller School of Medicine/Jackson Memorial Hospital, was lead author of the Phase 2 study.

Allogeneic human mesenchymal stem cells are derived from human adult donor bone marrow. Longeveron's randomized, double-blinded Phase 2 trial of MSCs involved 30 frail patients with an average age of 76. The patients were administered two doses of 100 million or 200 million cells versus placebo. Participants showed marked improvement in physical performance, lung function and inflammation biomarkers, all major aspects of frailty, with no serious adverse events attributable to the product.

Building on the positive data of the UM trials, Longeveron announced last month that it has initiated an expanded Phase 2b clinical trial of its proprietary Longeveron Mesenchymal Stem Cells (LMSCs) in accordance with an FDA Investigational New Drug (IND) application. The trial is designed to enroll 120 participants from 10 medical centers across the U.S., including the University of Florida and Stanford University.

According to the U.S. Census Bureau, the number of Americans 65 and older is projected to more than double to over 96 million by 2060, increasing to nearly 24% from 15% of the total U.S. population.

Longeveron's Phase 1 study can be accessed at https://doi.org/10.1093/gerona/glx056 and the Phase 2 study at https://doi.org/10.1093/gerona/glx137

About LMSCs

LMSCs are an allogeneic product, which means they are produced from stem cells derived from healthy adult donor bone marrow, and not from the patient's own stem cells (referred to as autologous). LMSCs are manufactured at Longeveron's cGMP Cell Processing Facility in Miami, Florida, using its proprietary processes.

About Longeveron

Longeveron is a regenerative medicine therapy company founded in 2014. Longeveron's goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company's research focus areas include Alzheimer's disease, Aging Frailty, and the Metabolic Syndrome, and gratefully acknowledges the generous support of the National Institutes of Health and the Alzheimer's Association. Longeveron is also conducting a Phase 1 trial with the University of Maryland and Johns Hopkins University to study Hypoplastic Left Heart Syndrome, a rare indication that affects infants, and gratefully acknowledges the support and collaboration from the Maryland Stem Cell Foundation. www.longeveron.com

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